AUTHOR=Kansu Aydan , Urganci Nafiye , Bukulmez Aysegul , Kutluk Gunsel , Gulcu Taskin Didem , Sahin Keskin Lutfiye , Igde Mahir , Molon Lutfi , Dogan Yasar , Sekerel Bulent Enis , Yuksek Mutlu , Bostanci Ilknur , Gerenli Nelgin , Polat Esra , Dalgic Buket , Ayyildiz Hasret , Usta Merve , Basturk Ahmet , Yuce Kirmemis Ozlem , Tuna Kirsaclioglu Ceyda , Gulerman Hacer Fulya , Alptekin Sarioglu Aysugul , Erdogan Simge
TITLE=Growth, tolerance and safety outcomes with use of an extensively hydrolyzed casein-based formula in infants with cow’s milk protein allergy
JOURNAL=Frontiers in Pediatrics
VOLUME=11
YEAR=2023
URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2023.1230905
DOI=10.3389/fped.2023.1230905
ISSN=2296-2360
ABSTRACT=ObjectiveTo evaluate growth, tolerance and safety outcomes with use of an extensively hydrolyzed casein-based formula (eHCF) in infants with cow’s milk protein allergy (CMPA).
MethodsA total of 226 infants (mean ± SD age: 106.5 ± 39.5 days, 52.7% were girls) with CMPA who received eHCF comprising at least half of the daily dietary intake were included. Data on anthropometrics [weight for age (WFA), length for age (LFA) and weight for length (WFL) z-scores] were recorded at baseline (visit 1), while data on infant feeding and stool records, anthropometrics and Infant Feeding and Stool Patterns and Formula Satisfaction Questionnaires were recorded at visit 2 (on Days 15 ± 5) and visit 3 (on Days 30 ± 5).
ResultsFrom baseline to visit 2 and visit 3, WFA z-scores (from −0.60 ± 1.13 to −0.54 ± 1.09 at visit 2, and to −0.44 ± 1.05 at visit 3, p < 0.001) and WFL z-scores (from −0.80 ± 1.30 to −0.71 ± 1.22 at visit 2, and to −0.64 ± 1.13 at visit 3, p = 0.002) were significantly increased. At least half of infants never experienced irritability or feeding refusal (55.7%) and spit-up after feeding (50.2%). The majority of mothers were satisfied with the study formula (93.2%), and wished to continue using it (92.2%).
ConclusionsIn conclusion, eHCF was well-accepted and tolerated by an intended use population of infants ≤ 6 months of age with CMPA and enabled adequate volume consumption and improved growth indices within 30 days of utilization alongside a favorable gastrointestinal tolerance and a high level of parental satisfaction.